Creating a brain response database using NeuroCatch® technology

Empirical Distributions of ERP Components Elicited by the NeuroCatch® Platform 2: Development of a Reference Interval Database

This study is trying to create a database of how healthy people's brains respond to sounds and words using a special technology, and it's open to anyone aged 6 and older.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 810 (estimated)
• Ages: 6 Years and up
• Sex: All
• Sponsor: HealthTech Connex Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Surrey, British Columbia)
• Trial ID: NCT06677424 on ClinicalTrials.gov

What this trial studies

This study aims to develop a reference interval database for brain responses to sounds and words using the NeuroCatch® Platform 2. It will enroll 810 healthy participants aged 6 and older, who will undergo a screening process followed by a brain scan to measure their brain activity. The study will collect demographic and health-related information to analyze variations in brain responses across different ages and sexes. The entire process will take approximately 30 minutes to 1 hour and can be completed in one or two visits.

Who should consider this trial

Good fit: Ideal candidates are healthy individuals aged 6 years and older who can understand the study procedures and provide informed consent.

Not a fit: Patients with hearing impairments, active tinnitus, or relevant neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into normal brain function, aiding in the diagnosis and treatment of neurological conditions.

How similar studies have performed: While similar studies have explored brain responses, this specific approach using the NeuroCatch® Platform 2 is relatively novel.

Eligibility criteria

INCLUSION CRITERIA

1. Any sex, at least 6 years of age or older
2. Able to understand the informed consent/assent form (in English), study procedures and willing to participate in study; participants under 19 must also have a parent/guardian who is able to understand and provide informed consent on their behalf.
3. Able to remain seated and focused for 7 minutes
4. In good health with no history of clinically relevant neurological illness or injury

EXCLUSION CRITERIA

1. Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to hearing (e.g., punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.
2. Implanted pacemaker or other electrical stimulator(s)
3. Metal or plastic implants in the skull, excluding dental/facial implants.
4. Not native-level in English
5. Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months
6. History of clinically relevant neurological disorders or injury (e.g., epilepsy, Parkinson's disease, traumatic brain injury, etc.)
7. History of chronic pain or chronic headache disorders (e.g. migraine, tension headaches, fibromyalgia, etc.)
8. Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia, etc.)
9. Diagnosed with any memory disorders.
10. History of clinically relevant major psychiatric disorders (e.g., schizophrenia, bipolar disorder, etc.)
11. History of alcohol or substance misuse that, in the opinion of the Investigator, may impact brain function
12. Use of medications that affect brain function (e.g., antiepileptic drugs, antipsychotics, stimulants, etc.)
13. Serious medical conditions affecting brain functions (e.g., stroke, brain tumor, neurodegenerative diseases, etc.)
14. Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function.
15. Unhealthy scalp (e.g., apparent open wounds and/or bruised or weakened skin)
16. Allergy to EEG gel

Where this trial is running

Surrey, British Columbia

• Centre for Neurology Studies, 13761 96 Ave, Unit 1004 — Surrey, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Jan Venter, MD — Centre for Neurology Studies
• Study coordinator: Sonia Brodie

Conditions Healthy Controls; Brain Function; Brain Scan, NeuroCatch®